Objective: To assess phosphate-binding efficacy of a new food product, bread with unusually high calcium content (Ca-bread).
Design and setting: A randomized parallel group trial in the university hospital outpatient dialysis unit.
Patients: Fifty-three randomly selected uremic patients who met the following inclusion criteria: (1) required maintenance hemodialysis treatment, (2) were not to receive vitamin D throughout the study, (3) were nondiabetic, and (4) were diagnosed with hyperphosphatemia.
Intervention: Fifty-three patients were randomized into 2 groups: control group (n = 26), which received calcium acetate as a phosphate binder throughout the study, and Ca-bread group (n = 27), which, after a 2-week washout period, received Ca-bread containing 2.5% of elemental calcium (by weight), which served as a phosphate binder. Bread was made using wheat flour, calcium carbonate, and fermented buttermilk. The amount of elemental calcium used as a phosphate binder was similar in both groups. Observation of both groups lasted 14 weeks.
Results: Mean serum phosphate concentration at randomization was 2.11 +/- 0.14 mmol/L in the control group and 2.20 +/- 0.13 mmol/L in the Ca-bread group. Mean serum calcium concentration at randomization was 2.12 +/- 0.21 mmol/L in the control group and 2.14 +/- 0.11 mmol/L in the Ca-bread group. The Ca-bread group patients' predialysis phosphate concentration decreased to a mean of 1.67 +/- 0.18 mmol/L (P <.05), and their mean calcium concentration increased to 2.27 +/- 0.11 mmol/L (P = NS). In the control group, neither value changed significantly from the original readings. After the hemodialysis session, the mean serum calcium concentration in the control group and the Ca-bread group increased by 7.5% and 7.9%, respectively (P = NS). Mean phosphate concentration simultaneously decreased to nearly 1/2 its original predialysis value in both groups. Ca-bread group patients saw a decrease in the mean phosphate concentration (from predialysis to postdialysis values) that was 13.8% greater than that of the control group (P = NS).
Conclusion: A new form of calcium-containing phosphate binder was developed: Ca-bread with an elemental calcium content of 2.5%. Ca-bread allows for effective amelioration of hyperphosphatemia without inducing hypercalcemia. Furthermore, patient compliance may increase if hyperphosphatemia can be treated by consuming bread with an elevated calcium content.